- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00926250
Effects of PS-IPC Supplementation on Muscle Mass and Functional Outcomes in Older Adults (PS-IPC)
Effects of Pro-Stat Immuno-Protein Complex (PS-IPC) Supplementation on Muscle Mass and Function, Inflammatory Markers, and Immune Function in Older Adults
Sarcopenia, the age-associated loss of skeletal muscle mass and strength, is a frequent precursor to functional impairment, disability, falls, and loss of independence in the elderly. The prevalence of sarcopenia is high, with ≥ 45% of the U.S. population aged 60 years or older sarcopenic. Some possible causative factors include a decline in muscle protein synthesis, inactivity, hormonal changes, pro-inflammatory conditions, and reactive oxygen species within the muscle mitochondria, which may all be exacerbated by inadequate nutritional intake. Since dietary protein is targeted to muscle and muscle mass represents the largest tissue in the body, protein nutrition plays a significant role in muscle metabolism.
SPECIFIC AIMS The specific aim of this proposed study is to determine the effect of PS-IPC supplementation on muscle mass, muscle strength, muscle quality, and inflammatory / immune markers in healthy older adults. Subjects scoring 4 - 10 on the Short-Physical Performance Battery and aged 60-85 years will consume PS-IPC supplements or placebo three times daily for 12 weeks.
HYPOTHESES
- Subjects consuming PS-IPC will have a greater increase in muscle mass and muscle strength compared to a control group consuming a placebo supplement.
- Subjects consuming PS-IPC will demonstrate a greater increase in the fractional rate of muscle protein synthesis compared with a placebo control group.
- Subjects receiving PS-IPC will have a reduction in plasma concentrations of various inflammatory markers of immune function, compared to subjects consuming the placebo.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Arkansas
-
Little Rock, Arkansas, Förenta staterna, 72205
- University of Arkansas for Medical Sciences
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- BMI of less than or equal to 35 kg/m2, be weight stable (+/- 5 kg) over the previous 4 months (via oral report), report the absence of alcohol or drug abuse, require minimal help in performing activities of daily living, and have a Short Physical Performance Battery score of 4 - 10.
Exclusion Criteria:
- Subjects with acute or chronic disease or who may be using drugs that might interfere with skeletal muscle metabolism / function or immune function will be excluded from participation. Other exclusion criteria include cognitive deficits identified by a Mini-Mental State Examination score < 24, mobility impairment requiring a wheelchair, infections, endocrine diseases (e.g., diabetes or untreated thyroid dysfunction), active inflammatory conditions, autoimmune disorders, renal dysfunction, anemia (hemoglobin < 11.5 g/dL), cardiac problems in preceding 3 months or congestive heart failure, chronic obstructive lung disease, neoplasia other than of the skin during the preceding 5 years, influenza vaccine within last 3 weeks or other vaccines within last 6 weeks, known systemic reaction to any immune function test antigen, and use of the following drugs: immunosuppressants, antianginal agents, antiarrhythmics, antibiotics within last 2 weeks, and oral steroids. Other conditions may be used as inclusion / exclusion criteria at the discretion of the study physician to ensure the safe participation of potential study subjects.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Placebotillskott
|
Each subject in this study will be provided the PS-IPC dietary supplement or placebo to consume three times per day for the 12-week duration of the intervention.
The placebo supplement will consist of an iso-caloric supplement designed to match the PS-IPC supplement in volume, color, consistency, and palatability.
|
Experimentell: PS-IPC supplementation
|
Each subject in this study will be provided the PS-IPC dietary supplement or placebo to consume three times per day for the 12-week duration of the intervention.
The placebo supplement will consist of an iso-caloric supplement designed to match the PS-IPC supplement in volume, color, consistency, and palatability.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Muscle protein synthesis
Tidsram: 14-16 months
|
14-16 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Body composition
Tidsram: 14-16 months
|
14-16 months
|
Skeletal muscle strength and function
Tidsram: 14-16 months
|
14-16 months
|
Immune function
Tidsram: 14-16 months
|
14-16 months
|
Physical activity level
Tidsram: 14-16 months
|
14-16 months
|
Self-perceived quality of life
Tidsram: 14-16 months
|
14-16 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Arny A Ferrando, PhD, University of Arkansas
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 109167
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Oral PS-IPC supplement
-
Irish Response t/a Lifes2goodStephens & Associates, Inc.AvslutadHårförtunningFörenta staterna
-
Abbott NutritionAvslutad
-
University of Illinois at ChicagoNational Heart, Lung, and Blood Institute (NHLBI)Anmälan via inbjudanFetma | Järnbrist | GraviditetsanemiFörenta staterna
-
Indonesia UniversityPT. Nutricia Medical NutritionAvslutadSvår akut undernäringIndonesien
-
Columbia UniversityNational Institute of Mental Health (NIMH); Impact Research & Development...Avslutad
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityAvslutadPrimär myelofibros | Anemi | Återkommande Hodgkin-lymfom | Refraktärt Hodgkin-lymfom | Anatomisk steg IV bröstcancer AJCC v8 | Återkommande akut myeloid leukemi | Återkommande myelodysplastiskt syndrom | Refraktär Akut Myeloid Leukemi | Refraktär kronisk myelomonocytisk leukemi | Refraktärt myelodysplastiskt... och andra villkorFörenta staterna